Medical Device Recalls

ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen

DePuy Orthopaedics, Inc.

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product

Olympus Corporation of the Americas

Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000

Stryker Medical Division of Stryker Corporation

HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Ra

Leica Biosystems Melbourne Pty Ltd

Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5

SunMed Holdings, LLC

RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

Biomerieux Inc

Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-70

Channel Medsystems, Inc.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 0

Medline Industries, LP

AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

Northgate Technologies, Inc.

TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK036

Edwards Lifesciences, LLC

Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE

Medline Industries, LP

BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9

CareFusion 303, Inc.

The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular im

Philips North America Llc

Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack numb

MEDLINE INDUSTRIES, LP - Northfield

GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test

Greer Laboratories, Inc.

Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 7

Philips North America

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

DEPUY (IRELAND)

PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intend

Philips North America

CombiDiagnost R90 1.0 (709030)

PHILIPS MEDICAL SYSTEMS

Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01

Beckman Coulter Inc.

Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.

Edwards Lifesciences, LLC

Discovery XR656HD. X-Ray imaging system.

GE Medical Systems, LLC

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagno

Medline Industries, LP

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. RO

MEDLINE INDUSTRIES, LP - Northfield

Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060

MICROspecialties, Inc.

Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08

AVID Medical, Inc.

ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.

Stryker Medical Division of Stryker Corporation

ACUSON Juniper Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cra

Medtronic Navigation, Inc.